Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-02 @ 1:12 PM
Study NCT ID:
NCT02604732
Status:
UNKNOWN
Last Update Posted:
2023-04-19
First Post:
2015-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-16', 'studyFirstSubmitDate': '2015-11-10', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hematoma', 'timeFrame': '24 hours', 'description': 'Postoperative scrotal or groin hematoma (not including skin bruising)'}], 'secondaryOutcomes': [{'measure': 'Incidence of seroma', 'timeFrame': '24 hours', 'description': 'Postoperative scrotal or groin seroma'}, {'measure': 'Incidence of hematoma requiring intervention', 'timeFrame': '30 days', 'description': 'Including blood transfusion, percutaneous drainage or surgical hemostasis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inguinal Hernia', 'Laparoscopic Inguinal Hernia Repair', 'Aspirin'], 'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '40616699', 'type': 'DERIVED', 'citation': 'Tan L, Yeow M, Fatt SLK, Parameswaran R, Mahipal M, Loo L, Wijerathne S, Lomanto D. Cessation vs no cessation of acetylsalicylic acid preoperatively in laparoscopic totally extraperitoneal inguinal hernia repair (CAPTAIN): final report from a multi-center, single-blinded, randomized-controlled trial. Hernia. 2025 Jul 5;29(1):221. doi: 10.1007/s10029-025-03418-4.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the need to stop Aspirin before elective laparoscopic inguinal hernia repair. It will consist of 2 arms: patients who continue to take Aspirin perioperatively and patients who stop Aspirin 5-7 days before the surgery.', 'detailedDescription': 'This study aims to assess the need to stop Aspirin before elective laparoscopic inguinal hernia repair. It will consist of 2 arms: patients who continue to take Aspirin perioperatively and patients who stop Aspirin 5-7 days before the surgery. Simple randomization will be performed and allocation is via closed envelope method. The surgeon will be blinded regarding the usage of Aspirin. The primary outcome is the incidence of post-operative hematoma formation within the first 24 hours after surgery. The secondary outcomes are the incidence of post-operative seroma formation within 24 hours, the incidence of post-operative hematoma requiring intervention (including blood transfusion, percutaneous drainage and surgical hemostasis) within 30 days, pain at regular intervals and the incidence of other post-operative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a diagnosis of inguinal hernia undergoing laparoscopic repair\n* Age 21-80 years\n* Patients taking Aspirin\n* BMI 18-30\n\nExclusion Criteria:\n\n* Age \\<21 and \\>80years\n* Recurrent inguinal hernia\n* Coagulopathy\n* Patients who can't stop Aspirin\n* BMI \\<18 and \\>30"}, 'identificationModule': {'nctId': 'NCT02604732', 'briefTitle': 'Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Randomized Controlled Trial on Pre-operative Withdrawal Versus no Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': '2015/00512'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients who stop Aspirin perioperatively', 'description': 'Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery', 'interventionNames': ['Procedure: Laparoscopic inguinal hernia repair without perioperative Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Patients who continue Aspirin perioperatively', 'description': 'Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively', 'interventionNames': ['Procedure: Laparoscopic inguinal hernia repair with perioperative Aspirin']}], 'interventions': [{'name': 'Laparoscopic inguinal hernia repair with perioperative Aspirin', 'type': 'PROCEDURE', 'description': 'Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively', 'armGroupLabels': ['Patients who continue Aspirin perioperatively']}, {'name': 'Laparoscopic inguinal hernia repair without perioperative Aspirin', 'type': 'PROCEDURE', 'description': 'Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery', 'armGroupLabels': ['Patients who stop Aspirin perioperatively']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Davide Lomanto, MD PhD', 'role': 'CONTACT', 'email': 'surdl@nus.edu.sg', 'phone': '+6567725903'}, {'name': 'Davide Lomanto, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sujith Wijerathne, FRCS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sean Lee, FRCS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Davide Lomanto, MD PhD', 'role': 'CONTACT', 'email': 'surdl@nus.edu.sg', 'phone': '+6567725903'}], 'overallOfficials': [{'name': 'Davide Lomanto, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}